The Recall Desk
ModerateFDA (Devices)·Z-1105-2015·Announced 2015-02-18

Teleflex Medical Recalls Aquapak 640 SW Humidifier Adaptors

Teleflex Medical is recalling Aquapak 640 SW humidifier adaptors because packages may contain foreign material, specifically black particles.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The presence of foreign material (black particles) in a sterile medical device package represents a contamination risk, but the source text does not report any specific injuries, illnesses, or deaths, placing this in the Moderate category rather than Severe or Critical.

Plain-English summary

Teleflex Medical is recalling the Aquapak 640 SW, 650ML W/040 Adaptor, French. This medical device accessory is used to connect sterile water or sterile saline to a humidifier circuit for inhalation therapy. The recall involves 15,779,607 units distributed worldwide, including the United States and numerous international markets.

The recall was initiated because the packages may contain foreign material, specifically black particles. The affected product code is 006-40F. Specific lot numbers involved in this recall include 147136, 103146, 015146, 102136, 153136, 023146, 040146, 001146, 056146, 115136, 052146, 132136, 008146, 110136, 159136, 165136, and 014146.

Healthcare providers and consumers should check their inventory for the specific product code and lot numbers listed above. If the product is found, it should be removed from use and returned to Teleflex Medical or the original supplier for credit or replacement.

The recalled product

Product
AQUAPAK 640 SW, 650ML W/040 ADAPTOR, FREN. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor pac
Manufacturer
Teleflex Medical
Category
Medical Device — Humidifier Adaptor
Hazard
Affected units
15,779,607

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • Product Code: 006-40F
  • Lot numbers: 147136
  • 103146
  • 015146
  • 102136
  • 153136
  • 023146
  • 040146
  • 001146
  • 056146
  • 115136
  • 052146
  • 132136
  • 008146
  • 110136
  • 159136
  • 165136 & 014146.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by Teleflex Medical under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 15 products in this recall →

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